Eli Lilly doubles down on Oblique partnership for antibody generation
Pharmaceutical Technology
AUGUST 23, 2024
The two companies have expanded their agreement first inked in 2023, with a second ‘high-value target’ now in the crosshairs.
Fri.Aug 23, 2024
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Two antibody startups file for IPOs amid summer slump
Bio Pharma Dive
AUGUST 23, 2024
Armed with clinical-stage data, Zenas BioPharma and Bicara Therapeutics both fit the profile of biotechs that have successfully pulled off IPOs this year.
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FDA approves updated mRNA vaccines for Covid-19
Pharmaceutical Technology
AUGUST 23, 2024
The US FDA has approved and granted EUA for Moderna and Pfizer-BioNTech’s updated mRNA Covid-19 vaccines, Comirnaty and Spikevax.
FDA to convene immunotherapy panel; Tome scales back operations
Bio Pharma Dive
AUGUST 23, 2024
Agency advisers will discuss whether use of Keytruda and Opdivo should be limited in gastric cancer. Elsewhere, a buzzy genetic drug startup is exploring “strategic options.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Bayer layoffs hit Switzerland with 150 cuts at Basel consumer health hub: reports
Fierce Pharma
AUGUST 23, 2024
Bayer’s latest round of layoffs has reportedly hit Basel, Switzerland, home of the international headquarters of the company's consumer health division. | The layoffs are the latest in Bayer's massive restructuring plan that has so far impacted more than 3,000 staffers since the start of the year.
AstraZeneca may pull plug on UK vaccine manufacturing plans
Pharmaceutical Technology
AUGUST 23, 2024
AstraZeneca may relocate its vaccine manufacturing plans from the UK to US as the finance minister discusses financing cuts.
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Jazz’s cannabidiol therapy flunks in Japanese Phase III trial
Pharmaceutical Technology
AUGUST 23, 2024
Jazz’s cannabidiol oral solution, Epidiolex, is approved as an adjunct seizure treatment for three epileptic conditions in the US and Europe.
Association for Medical Education in Europe AMEE 2024 conference
Pharma Times
AUGUST 23, 2024
The conference will be held in Basel, Switzerland from 26-28 August
VION Biosciences acquires Echelon Biosciences
Pharmaceutical Technology
AUGUST 23, 2024
VION Biosciences has announced the acquisition of Echelon Biosciences, known for its supply of materials such as lipid-based excipients.
As sales climb, Jazz's Epidiolex falls short in Japanese study in treatment-resistant epilepsies
Fierce Pharma
AUGUST 23, 2024
While some analysts figure Jazz Pharmaceuticals’ Epidiolex—sold as Epidyolex abroad—could surpass the blockbuster sales threshold by the end of the decade, the cannabidiol-based seizure drug has st | On Friday, Jazz revealed that its Epidiolex oral solution failed to mass muster in a late-stage study when used as an adjunct treatment for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in young Japanese patients.
Rafael Holdings and Cyclo Therapeutics enter merger deal
Pharmaceutical Technology
AUGUST 23, 2024
Rafael Holdings has signed a definitive merger agreement with Cyclo Therapeutics aiming to enhance the development of Trappsol Cyclo.
MHRA approves Astellas’ Vyloy combination for gastric cancer
Pharma Times
AUGUST 23, 2024
Most cases go undetected until an advanced stage, as the disease rarely causes early symptoms
A comprehensive guide to supply chain management for specialty drugs
Pharmaceutical Technology
AUGUST 23, 2024
Integrating sustainable solutions within supply chains is imperative to ensure long-term environmental and economic viability.
Power to the patients: Patient organisations enabling drug development
pharmaphorum
AUGUST 23, 2024
Discover how patient organizations play a key role in enabling drug development with the support of EFPIA. Learn more about their involvement and impact in the pharmaceutical industry.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharma Pulse 8/23/24: Pfizer/BioNTech FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine, Hidden Obstacles in the Script-to-Therapy Journey & more
Pharmaceutical Commerce
AUGUST 23, 2024
The latest news for pharma industry insiders.
AstraZeneca dismisses rumours of facility relocation to US
pharmaphorum
AUGUST 23, 2024
AstraZeneca says rumours that it will relocate a planned vaccines facility from the UK to the US "do not seem to be based on facts"
What Chevron’s overturn means for biopharma
Fierce Pharma
AUGUST 23, 2024
For the last 40 years, when federal legislation was ambiguous or left an administrative ga | This week on "The Top Line," we look at the potential effects of the Chevron overturn on the biopharma industry.
Versant, Novartis team up again in hunt for another Chinook
pharmaphorum
AUGUST 23, 2024
Novartis and VC Versant set up a new biotech, Borealis Biosciences, using a similar model to an earlier alliance to create Chinook Therapeutics
New XpressGT kit speeds up diagnosis of diabetes, endometriosis and liver disease
Outsourcing Pharma
AUGUST 23, 2024
DirectSens, an Austrian biosensor developer, has launched its latest innovation, the XpressGT RUO kit, designed for the detection of conditions related to insulin resistance, including gestational diabetes (GDM), endometriosis, and liver disease.
US immunology biotech Zenas BioPharma files $100m IPO
pharmaphorum
AUGUST 23, 2024
Zenas BioPharma has filed an initial public offering in the US seeking $100m+ for obexelimab, a therapy for rare disease IgG4-RD in phase 3
EC Approves Balversa for patients with metastatic urothelial carcinoma
Outsourcing Pharma
AUGUST 23, 2024
Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has approved Balversa (erdafitinib) as a once-daily oral monotherapy for adult patients with unresectable or metastatic urothelial carcinoma (mUC) harboring susceptible FGFR3 genetic alterations.
New COVID-19 jabs approved by FDA for 2024-25 season
pharmaphorum
AUGUST 23, 2024
The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2 strain of SARS-CoV-2 which was dominant in the US in recent months.Both new mRNA-based vaccines have been approved for use in people aged 12 and over – and been granted emergency use authorisation for younger people aged 6 months to 11 years – and will be available within the next few days, said the drugmakers.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Recording of Hybrid Public Workshop Now Available: AI in Drug and Biological Product Development
CTTI (Clinical Trials Transformation Initiative)
AUGUST 23, 2024
The recording for the hybrid public workshop on AI in Drug and Biological Product Development convened and hosted by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held August 6, is now available. Over 9,000 registrants from diverse backgrounds and perspectives joined to explore the responsible use of AI in drug development.
ICER says Geron's just-approved Rytelo is too pricey
pharmaphorum
AUGUST 23, 2024
ICER says Geron's new drug Rytelo for myelodysplastic syndromes (MDS) is priced three to four times higher than it should be
Quantitative MRI Imaging in Orthopedic Clinical Trials
WCG Clinical
AUGUST 23, 2024
Historically, clinical trials of therapeutic outcomes in arthritis have primarily relied on patient questionnaires for assessing progression of disease, focused on clinical parameters including pain, quality of life, and joint function. Sole reliance on clinical parameters has several limitations however, including the inherent subjectivity involved in the assessment of patient experience, as well as the necessity that a patient exhibit overt symptoms.
Driving growth with connected health
pharmaphorum
AUGUST 23, 2024
Discover how apps and telemedicine are driving growth in the healthcare industry with connected health solutions. Learn about the impact of technology on patient care and access to services.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
The New Penal Provisions in the Drugs and Cosmetics Act
Pharma Tutor
AUGUST 23, 2024
The New Penal Provisions in the Drugs and Cosmetics Act admin Sat, 08/24/2024 - 11:28 In a bid to decriminalise and rationalise offences to further enhance trust-based governance for ease of living and doing business, the Jan Vishwas (Amendment of Provisions) Act, 2023 was published in the Gazette of India, Extraordinary, Part II – Section 1, No. 21 on the 11th August, 2023.
Tech & Trials: What’s all this about AI, then?
pharmaphorum
AUGUST 23, 2024
Learn about the fascinating world of artificial intelligence (AI) and machine learning in this informative article. Explore the concepts, applications, and impact of AI in various industries.
Why Integration with eTMF and EDC is Crucial for a Unified Clinical Trial Management
Cloudbyz
AUGUST 23, 2024
In the ever-evolving landscape of clinical trials, the demand for efficiency, accuracy, and compliance has never been higher. As trials become more complex and global, the need for unified systems that can seamlessly manage data across multiple platforms is critical. At the heart of this unification is the integration of Clinical Trial Management Systems (CTMS) with Electronic Trial Master Files (eTMF) and Electronic Data Capture (EDC) systems.
FDA Approves Updated Moderna, Pfizer COVID-19 Vaccines for Omicron KP.2 Variant
Pharmaceutical Commerce
AUGUST 23, 2024
The updated COVID vaccine replaces previous bivalent vaccines, focusing on a single strain for more effective immunity.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
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